1. Field of the Invention
The present invention is directed generally to methods of female genital skin reduction, improvement of skin tone and treatment of female urinary incontinence, as well as the treatment or improvement of other clinical conditions involving the female genitalia.
2. Description of the Related Art
The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
Urinary incontinence is a global problem afflicting an estimated 200 million people worldwide. Urinary incontinence is a stigmatized, underreported, under-diagnosed, under-treated medical condition that is erroneously thought to be a normal part of aging. Up to one in four women over the age of 18 experience episodes of leaking urine involuntarily. There are several forms of incontinence.
The type of incontinence that statistically affects most women, which is the focus of medical and surgical procedures for the correction of female incontinence—stress urinary incontinence—is the leaking of urine during physical movements such as coughing, sneezing, walking or exercising, when there is pressure on the bladder. Childbirth, menopause and aging can weaken the pelvic floor muscles, the vagina and the ligaments that support the bladder. When the supporting structures are weakened, the bladder and vaginal walls can move downward, altering the urethral position and keeping the muscles from squeezing as tightly as they normally could. Without a tightly sealed urethra, urine can leak during movements of physical stress.
Another type of incontinence—urge incontinence—involves losing urine after inappropriate bladder spasms or contractions of the detrusor muscle, usually at unexpected times such as touching or hearing the sound of water, during sleep, or after drinking water, is commonly treated with anti-cholinergic medications.
Yet another type of incontinence, and one which is very common among post-menopausal women, is mixed incontinence—a combination of stress and urge incontinence. Most women do not have pure stress or pure urge incontinence, and it has been suggested that mixed incontinence may be the most common type of urinary incontinence among women.
Much less common is a condition known as overactive bladder, which occurs when nerves send signals to the bladder at the wrong time, day and night, when the bladder is not full, causing the muscles to squeeze without warning.
Relatively rare in women are overflow incontinence, when the bladder doesn't empty properly causing urine to spill over, and functional incontinence, which happens to women with impaired thinking, moving or communicating making it hard for them to reach the toilet.
Transient incontinence is leaking that occurs temporarily due to a medication effect, urinary tract infection or restricted mobility from an injury. For example, a respiratory infection can trigger transient incontinence, which resolves when coughing ends.
Both stress and urge incontinence become more frequent with age and are most prevalent at the time of menopause, approximately age 50, and again at age 65. See R. G. Rogers, Urinary Stress Incontinence in Women, N. Engl. J. Med., 358(10):1029-36 (Mar. 6, 2008). Obesity, multiple pregnancies/deliveries and white race are known to be risk factors for incontinence, with obese women having twice the risk of leaking compared to non-obese women. See K. Strohbehn, Shades of dry—curing urinary stress incontinence, N. Engl. J. Med., 356(21):2198-200 (May 24, 2007; epub May 21, 2007).
The social costs of urinary incontinence are high and even mild symptoms will affect social, sexual, interpersonal, and professional function. Many women make adaptations to their activity level and even stop participating in exercise to avoid embarrassment, which impacts their health, overall fitness level and quality of life. Maintaining an active lifestyle is an important aspect to treating incontinence.
Incontinence can lead to feelings of shame and embarrassment and lead to low self esteem. Intimate relationships are often affected because of urine odor, pad use and frequent trips to the toilet. The fear of a major leaking accident when in public leads most incontinence sufferers to eventually become socially isolated. Fifty-three percent of homebound older persons are incontinent and more than half of all residents in nursing homes are incontinent, with incontinence being the second leading cause of institutionalization in the U.S. and the cost of caring for urinary incontinence in nursing facilities estimated at $5.3 billion.
The costs to our healthcare system and to society from incontinence are riveting. In 1995, the societal cost of incontinence for individuals over 65 years of age and older was $26.3 billion, or $3,565 per individual with urinary incontinence, with most of the total cost associated with direct treatment, such as diagnostic testing and medication.
The medical and surgical solutions for the problem of incontinence are invasive, require either local or general anesthesia, hospitalization, require time for recovery and healing, involve significant potential risks including hemorrhage, prolonged urinary retention, infection, urethral obstruction, de novo urge incontinence, damage to the surrounding tissue and erosion through tissue. The medical and surgical solutions presently available to women treat severe, daily symptoms of urinary incontinence but do not treat mild to moderate symptoms and do not treat preventatively.
Medical and surgical treatments for female urinary incontinence are customized methods aimed at improving either intrinsic urethral tone or improving extrinsic urethral tone. By way of example, U.S. Pat. No. 5,112,344 describes a method for surgical treatment of female urinary incontinence where a looping filamentary element is placed between the vaginal wall and rectus abdominis sheath and passed on each side of the urethra in an attempt to correct the urethral position by encouraging the development of a scar tissue, thereby improving extrinsic urethral support. Another example is U.S. Pat. No. 5,899,909, which discusses a surgical method used to treat female urinary incontinence where tape is passed into the body through the vagina on either side of the urethra to form a loop around the urethra, which is tightened and attached to the abdominal wall, in an attempt to give the urethra added extrinsic support and tone. Yet another example is U.S. Pat. No. 6,406,423, which describes another method for surgical treatment for urinary incontinence; this one, involving forming openings suprapubically and vaginally and forming tracks, verifying tracks by cystoscopy, passing a sleeved tape through these tracks to form a loop under the urethra, tightening the loop, removing the sleeve and leaving the tape implanted under the urethra, to give the urethra added extrinsic support and tone. Still another example is U.S. Pat. No. 7,112,171, which discusses a sling assembly with secure and convenient attachment, as an improved and potentially safer instrument for performing the urethral sling surgical method, a procedure involving placement of a sling made of mesh or tape to stabilize or support the urethra extrinsically. The sling procedure has potential complications of urethral obstruction, development of de novo urge incontinence, hemorrhage, prolonged urinary retention, infection and damage to the surrounding tissue and sling erosion.
There are other concerns regarding the sling device. Many midurethral slings and related devices have received approval from the FDA through a 510(k) process that does not require proof of safety and efficacy of the new device, but requires evidence that something similar has already been approved for use. After a particular sling device was approved through a 510(k) process and put into use before clinical trials were conducted, this device unfortunately resulted in erosion through the vaginal wall, causing pain and bleeding for women, and had to be removed from the market. See Strohbehn.
U.S. Pat. No. 5,957,920 discusses in its background other options for treatment of urinary incontinence, including injection of collagen around the urethra attempting to improve intrinsic tone of the urethra. This patent describes a method for treating urinary incontinence using radiofrequency waves to thermally damage cells of the internal urethra, thereby promoting scar tissue, attempting to improve intrinsic urethral tone.
Each of the aforementioned approaches to female genital skin reduction, improvement of skin tone and/or treatment of female urinary incontinence suffers from drawbacks. In fact, current methods for treatment of female urinary incontinence are invasive, require recovery time and are expensive. These methods also involve potential risks including the injection or placement of foreign substances or objects into the body, general anesthesia, overcorrection of the urethral tone leading to urethral obstruction, development of new urge incontinence, infection, hemorrhage, as well as scarring and erosion of a foreign body through the urethral tissues resulting in chronic pain and bleeding. Moreover, current methods of treatment of female urinary incontinence are not effective in preventing urinary incontinence, which is known to be a condition that progressively worsens as women advance in age through menopause and beyond.
There is a need for a completely non-invasive treatment for urinary incontinence and for a treatment that can be used to treat women in the early stages of incontinence as well as treat incontinence preventatively. The present invention overcomes the deficiencies and risks of previous medical and surgical procedures for female urinary incontinence, and also provides features and advantages not previously found in other methods and technologies. The present invention provides these and other advantages as will be apparent from the following detailed description and accompanying figures.